Increasing Condom Use in People at Risk for HIV Infection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID). Recruitment status was: Active, not recruiting

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00080093

First Posted: March 24, 2004

Last Update Posted: September 26, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4

Behavioral: Individual feedback and specially-tailored manuals

Individual feedback and specially-tailored manuals

Experimental: 2

Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4

Behavioral: General HIV information feedback and the best-available information

General HIV information feedback and the best-available information

Detailed Description:

As heterosexual HIV transmission increases, effective behavioral interventions to increase condom use are needed. Interventions should be low cost and accessible to large segments of the at-risk population. This study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. The intervention is computer-delivered and will be provided in health care settings. The study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the Multifaceted Model of HIV Risk.

Participants will be recruited from four health clinic sites that serve local ethnic minority communities. The participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an HIV information comparison group. All participants will receive comparable group-specific informational materials at study entry and at Months 2 and 4. Participants in the intervention group will receive individualized feedback and specially-tailored manuals. Participants in the HIV information comparison group will receive general HIV information feedback and the best-available informational manual.

Assessments for both groups will be conducted at study entry and at Months 6, 12, and 18. At study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. There will also be computer question sessions at study entry and at Months 2 and 4. Participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (STD) history, and personal relationships. Telephone follow-ups at Months 6, 12, and 18 will take approximately 20 to 30 minutes.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 44 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria

HIV uninfected

Sexually active

At risk for HIV (as determined by study officials)

Speaks English

Seen at a participating clinic

Exclusion Criteria

Pregnant

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080093